Effectiveness of Siponimod with Up to 2 Years of Treatment in a Real-World Setting in People with SPMS: Analysis from the Novartis Global Managed Access Program
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Published on: September 5, 2018
Antonio Carotenuto1, Dimitris Naoumis2, Vincenzo Brescia Morra1
1Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University of Naples, Naples, Italy.
Background:
Limited real-world data exist on the effectiveness of siponimod in people living with secondary progressive multiple sclerosis (plwSPMS).
Objective:
To analyze the real-world data of patients receiving siponimod under a managed access program (MAP).
Methods:
The MAP was implemented in countries where siponimod was not approved and provision via MAP was permitted under local regulations. Data on the demographic/clinical characteristics and clinical outcomes of the cohort included in this MAP between February 2019 and April 2022, were collected from physicians using a Novartis database.
Results:
Among patients with evidence of starting siponimod treatment in the MAP (n=516), the mean EDSS at baseline was 5.2. Among those with post-baseline data available (n=423), the mean change from baseline in EDSS score at month 6 was -0.04 (95% confidence interval [CI]: -0.10, 0.01) and 0.03 (95% CI: -0.03, 0.10) at month 24), and the annual relapse rate was 0.023. Cognition was stable or improved in patients for whom data was available. Among patients with ≥1 MRI assessment (n=165), 154 (93.3%) had no findings of disease activity.
Conclusion:
This real-world data set analysis provides data on the demographic/clinical characteristics of plwSPMS taking siponimod in clinical practice under MAP criteria and on the effectiveness that can be attained.
